Feds Relent On Long-Delayed Pot For PTSD Study

High Times writes about the U.S. Health and Human Services’ March 14, 2014, approval of MAPS’ protocol for a study of effects of medical marijuana as a treatment for symptoms of PTSD in U.S. veterans. The article details previous political obstacles surrounding the commencement of this research and explores other studies looking into the medical potential of marijuana. “Regulators at the US National Institute on Drug Abuse (NIDA), the federal agency that must approve the use of cannabis in any FDA-approved clinical study, have consistently stood in the way. That is, until this month,” explains Paul Armentano of High Times.

Originally appearing here.

Health professionals, patients and state lawmakers are increasingly advocating for cannabis as a therapeutic option to address the stress and painful memories associated with post-traumatic trauma. Yet, to date, virtually no controlled clinical data exists assessing the plant’s use by patients diagnosed with PTSD (post traumatic stress syndrome).
For the past several years, researchers at the University of Arizona College of Medicine and at the non-profit drug development group MAPS (Multidisciplinary Association for Psychedelic Studies) have sought to change this fact. Yet despite gaining FDA approval in 2010 to study the effects of cannabis versus placebo in war veterans, no subjects have yet to be enrolled in the trial. The reason? Regulators at the US National Institute on Drug Abuse (NIDA), the federal agency that must approve the use of cannabis in any FDA-approved clinical study, have consistently stood in the way. That is, until this month.
On March 12, Sarah A. Wattenberg, Senior Advisor at the Public Health Service (PHS) sent a letter to MAPS informing the group that they have recommended that NIDA provide marijuana for their revised protocol, entitled “Placebo-Controlled, Triple-Blind, Randomized Crossover Pilot Study of the Safety and Efficacy of Five Different Potencies of Smoked or Vaporized Marijuana in 50 Veterans with Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD).”
The recommendation marks a significant shift in PHS and NIDA policy. In particular, NIDA has previously discouraged clinicians from submitting research protocols to the agency that sought to investigate potential benefits associated with the plant. “As the National Institute on Drug Abuse, our focus is primarily on the negative consequences of marijuana use,” Shirley Simson, a spokeswoman for the agency told The New York Times in 2010. “We generally do not fund research focused on the potential beneficial medical effects of marijuana.”
But that stance may be changing, due in large part to the persistence of MAPS and the study’s lead researcher Suzanne A. Sisley, clinical assistant professor of psychology at the University of Arizona. “We never relented,” she told The Los Angeles Times in regards to their four-year battle with the agency. “But most other scientists have chosen not to even apply. The process is so onerous. … This is a great day. The merits of a rigorous scientific trial have finally trumped politics.”
While representatives from the US Drug Enforcement Administration must still sign off on the trial — an additional hurdle that exists for all FDA-approved protocols involving a schedule I prohibited substance — the study’s investigators do not expect the anti-drug agency to halt the trial from finally moving forward.
Once approved, the privately funded pilot trial will assess potential risks and benefits associated with the use of cannabis for war veterans suffering from PTSD, including the plant’s potential impact on subjects’ anxiety, suicidality, and depression. Recent brain imaging research provides researchers with a reason to be optimistic about the plant’s prospects as a potential agent in the treatment of traumatic memories. According to a May 2013 study published in the journal Molecular Psychiatry, subjects diagnosed with PTSD may experience a decrease in their natural production of anandamide, an endogenous cannabinoid neurotransmitter, resulting in an imbalance in the brain resulting in excessive fear and anxiety. “The data reported herein are the first of which we are aware of to demonstrate the critical role of CB1 (cannabinoid) receptors and endocannabinoids in the etiology of PTSD in humans,” the study’s authors concluded.
A separate review published in 2012 in the journal Drug Testing & Analysis similarly acknowledged: “Cannabis may dampen the strength or emotional impact of traumatic memories through synergistic mechanisms that might make it easier for people with PTSD to rest or sleep and to feel less anxious and less involved with flashback memories.” Authors concluded, “Evidence is increasingly accumulating that cannabinoids might play a role in fear extinction and anti-depressive effects.”